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The PointCare NOW System is an automated hematology system intended for in vitro diagnostic use in performing the direct enumeration of major white blood cell populations, certain T-lymphocyte subsets, and hemoglobin concentration from human whole blood.

Whole blood samples can be analyzed with the PointCare NOW System for the following parameters:

• White Blood Cell Count
• Lymphocyte Count
• Lymphocyte Percentage (of White Blood Cells)
• CD4 T-Lymphocyte Count
• CD4 Percentage (of total Lymphocytes)
• Monocyte Count
• Monocyte Percentage (of White Blood Cells)
• Neutrophil Count
• Neutrophil Percentage (of White Blood Cells)
• Eosinophil Count
• Eosinophil Percentage (of White Blood Cells)
• Hemoglobin Concentration

The PointCare NOW System and its methods for immune hematology analysis are intended for in vitro diagnostic use in clinical laboratory settings.

The PointCare NOW System is a compact bench top immune hematology system that from analysis of a whole blood sample reports the hematology parameters identified within the Intended Use section below. The PointCare NOW System consists of an analysis instrument with an integrated touch screen interface and a commercially available tape roll printer.

The CD4NOW Gold Pack is used within the PointCare NOW System and all assay steps are performed on whole blood with capped bar-coded reagents designed for use on the PointCare NOW System. All assay aspiration, dispensing and mixing steps are automated. The PointCare NOW System reports parameter results on the basis of software analysis of light scatter measurements with the use of non-fluorescent reagents. Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation.

The PointCare NOW System is an automated immune hematology system designed for in vitro diagnostic use, performing direct enumeration of major white blood cell populations, certain T-lymphocyte subsets, and hemoglobin concentration from human whole blood.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria for each parameter (e.g., specific ranges for precision, linearity, or acceptable bias compared to reference methods). Instead, it describes general positive outcomes of the testing.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: "A multi-site prospective study was conducted at four investigational sites to evaluate the performance of the PointCare NOW System with other commercially available methods. A total of evaluable samples were analyzed across all participating sites." The specific numerical total of evaluable samples is not provided in the summary.
• Data Provenance: The study was a "multi-site prospective study," indicating the data was collected specifically for this evaluation. The country of origin is not explicitly stated, but the sponsor is a US company (Marlborough, MA), and the FDA 510(k) process is for devices marketed in the United States, suggesting the study likely took place in the US or in a region using similar clinical standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the summary. The clinical testing describes a comparison to "other commercially available methods" (reference methods), but it does not specify direct expert interpretation or a panel of experts to establish a "ground truth" that would be distinct from the output of the reference methods themselves.

4. Adjudication Method for the Test Set

This information is not provided in the summary. Since the comparison is against "commercially available methods" (likely established laboratory analyzers), it's improbable that a separate adjudication process involving human experts to resolve discrepancies was conducted in the typical sense for image interpretation or diagnosis. Instead, the reference methods are likely considered the "ground truth" or standard for comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described for this device. The PointCare NOW System is an automated analyzer, meaning it generates results without direct human interpretation in the workflow. The summary explicitly states: "Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation." Therefore, the concept of "human readers improving with AI assistance" does not apply to this device's intended use according to the provided information.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance evaluation was done. The entire premise of the PointCare NOW System, as described, is its automated nature. The summary states: "Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation." The clinical testing directly evaluates the performance of the PointCare NOW System (the algorithm/device as a whole) against reference methods.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by "other commercially available methods" which served as "reference methods." These would typically be established, FDA-cleared or CE-marked hematology analyzers or flow cytometers that are widely accepted in clinical laboratory settings. This implicitly means the ground truth is derived from established laboratory analysis/measurement, not pathology review, expert consensus on images, or long-term outcomes data.

8. The Sample Size for the Training Set

This information is not provided in the summary. The document describes performance testing for regulatory submission but does not delve into the development or training of the internal software/algorithms.

9. How the Ground Truth for the Training Set was Established

This information is not provided in the summary. As the document focuses on regulatory performance testing, details about the internal development and training of the device's algorithms or the ground truth used during that stage are not included.

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The FlowCare System is an automated immune hematology system intended for in vitro diagnostic use in the direct enumeration of White Blood Cell populations and certain T-lymphocyte subsets from human whole blood.

Whole blood samples can be analyzed with the FlowCare™ System for the following parameters:

• White Blood Cell Count .
• Lymphocyte Percentage (of White Blood Cells)
• . Lymphocyte Number
• CD4 T-Lymphocyte Count .
• CD4 Percentage (of total Lymphocytes) .

The FlowCare System and its methods for immune hematology analysis are intended for in vitro diagnostic use in clinical laboratory settings.

The FlowCare System is a compact benchtop immune hematology system that reports CD4 T-Lymphocyte count and percentage in conjunction with White Blood Cell (WBC) count, and total Lymphocyte count and percentage from analysis of a whole blood sample. The FlowCare System is comprised of an analysis instrument, a touch screen computer and a standard inkjet printer. The FlowCare CD4 Reagent Kit is used in conjunction with the FlowCare System.

All assay steps are performed on whole blood with capped bar-coded reagent tubes designed for use on the FlowCare System. All assay aspiration, dispensing and mixing steps are automated. The FlowCare System reports parameter results on the basis of software analysis of light scatter measurements with the use of nonfluorescent reagents. Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation.

Here's a breakdown of the acceptance criteria and study information for the FlowCare™ System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the performance of the FlowCare™ System in various studies but does not explicitly state quantitative acceptance criteria or thresholds for metrics like accuracy, sensitivity, or specificity. Instead, it uses qualitative statements about the results. Therefore, the table below reflects the qualitative findings as reported.

2. Sample Size for the Test Set and Data Provenance:

• Sample Size for Test Set: A total of 414 evaluable samples were analyzed in the multi-site prospective clinical study.
• Data Provenance: The study was a prospective study conducted at four investigational sites. The country of origin of the data is not explicitly stated, but given the FDA review and the sponsor's location (Ashland, MA), it is highly likely that the data originated from the United States.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. It states that "analyses were performed for comparison of the FlowCare method to the reference methods," implying that the reference methods provided the ground truth.

4. Adjudication Method:

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The clinical study compares the FlowCare™ System's performance to "other commercially available methods" (reference methods), not the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone performance study was done. The FlowCare™ System is described as an "automated immune hematology system" where "automated cell population cluster analysis is performed by the software and results provided with no operator interpretation." This indicates that the device operates as an algorithm-only (standalone) system without direct human intervention in the interpretation of results for the listed parameters. The clinical testing evaluates this standalone performance against reference methods.

7. Type of Ground Truth Used:

The ground truth used for the clinical study was based on "other commercially available methods" (reference methods). These reference methods would likely be established and validated laboratory tests (e.g., flow cytometry or hematology analyzers) that are considered the standard for measuring White Blood Cell populations and T-lymphocyte subsets.

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set. It only describes the performance and clinical validation studies. As it is a 510(k) summary, specific details about the internal algorithm development and training data are typically not included.

9. How the Ground Truth for the Training Set Was Established:

The document does not provide information on how the ground truth for the training set was established. This detail would typically be part of the algorithm development process, which is not described in this 510(k) summary.

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